Kornimate/medical-research-clean huggingface dataset:
primary needle knife fistulotomy

Conditions: Pancreatitis

Summary: evaluate the outcomes of nkf as an initial method for biliary access.

introduction a previous feasibility study has suggested that needle knife fistulotomy (nfk) as an initial method for biliary access in patients with stones is associated with high levels of success and low rate of complications. this study evaluated the outcomes of nkf as an initial method for biliary access, in a large number of patients with any type of biliary pathology (tumors and stones), on the basis of success rate, complications and factors associated with success and complications. financial resources all participants included in this study will perform ercp, laboratory tests and other complementary diagnostic tests after a duly justified medical prescription. therefore there are no additional costs or consumption of hospital resources. ethical considerations in this study, participants will be included after informed consent. anonymity and confidentiality will be safeguarded by assigning an individual numeric code. it will also be explained the possibility of withdrawing from the study at any time, with the guarantee of the total elimination of data. all researchers involved in the study will adhere to the rules of ethical conduct and best practices in order to comply with the precepts of the declaration of helsinki, the convention on human rights and biomedicine, the guidelines of the council for international organizations of medical sciences and the guide to good clinical practice. statistical analysis qualitative variables will be summarized using absolute and relative frequencies, and quantitative variables will be summarized using the mean and standard deviation or the median and interquartile range, depending on their distribution profiles. the normality of the quantitative variables will be assessed using the histogram distribution. relations between categorical variables will be assessed using a chi-square test and fisher´s exact test. differences between two or more groups of independent non-normally distributed quantitative variables will be evaluated using a kruskal-wallis test. to explain the risk of pancreatitis, a binomial logistic regression model with multiple predictors will be performed. the null hypothesis will be rejected when the test statistics p-values are less than \<0.05. statistical analysis, sample size calculation and graphics will be performed using stata software (statacorp. 2015. stata statistical software: release 14. college station, statacorp lp) expected results the results of this study will contribute to a better understanding of what is the best algorithm to follow when performing an ercp.

Eligibility criteria:
inclusion criteria: * ercp with indication for biliary access * naïve papilla exclusion criteria: * patients unable to sign or understand the informed consent * patients with surgically altered anatomy * patients with tumors of the papilla * previous sphincterotomy * spontaneous papillary fistula * papilla not visualized

Keywords: ercp biliary cannulation needle-knife fistulotomy standard cannulation methods
clindamycin and triamcinolone in people with glioblastoma to prevent skin-related side effects of tumor treating fields

Conditions: Glioblastoma; Recurrent Glioblastoma; Skin Toxicity

Summary: the participants are being treated with tumor treating fields (ttfields) for malignant glioma, and this type of treatment may cause skin-related side effects. this study will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects of ttfields.


Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of newly diagnosed or recurrent gbm with plan to initiate treatment with ttfields with or without systemic therapy, confirmed by the enrolling institution * able to self-administer topical interventions or has available another person who can apply the topical agents * treatment with ttf should be initiated within 7 days of planned initiation on this trial. exclusion criteria: * known history of allergy to any ingredient of the study agents * preexisting scalp disorders such as psoriasis or dermatitis that, in the opinion of the investigator, will affect the grading of skin adverse events, confirmed by enrolling institution. * use of concurrent topical therapy to the scalp for another dermatologic condition * active, uncontrolled infection requiring systemic or oral antibiotic therapy within 14 days of enrollment * use of greater than 4 mg dexamethasone a day within 14 days of enrollment * malignant glioma * pregnant women

Keywords: clindamycin triamcinolone skin-related side effects recurrent 19-342
the effect of electroacupuncture on obesity

Conditions: Obesity

Summary: the purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity.

many studies have reported on the beneficial effects of acupuncture for obesity, although some negative reports also existed.(wang f. et al. 2008)recently conducted systematic review of pittler and ernst reported that there was insufficient, but not conclusive evidence to support the efficacy of acupuncture and acupressure for weight loss. however, most of these studies had methodological limitation, such as lack of adequate control group or unclear specific effect of electroacupuncture alone because auricular acupuncture was administered as well. in this sudy, we had three-arm randomized controlled trial(with sham control group) to investigate whether electroacupuncture is effective in the treatment of obesity.

Eligibility criteria:
inclusion criteria: * waist circumference: male\>= 90 cm, female \>= 85 cm * bmi over than 25kg/m2 exclusion criteria: * secondary obesity caused by endocrine disease, e.g., polycystic ovary syndrome, diabetes mellitus, cushing's syndrome, hypothyroidism etc. * heart disease,e.g.,arrhythmia, heart failure, myocardial infarction, and patient with pacemaker * hypertension, hyperlipidemia or hypercholesterinemia patients on medication * stroke or otherwise unable to exercise * pregnant or lactating women * childbirth within 6 months * management for weight control within 3 months * any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge

Keywords: obesity electroacupuncture sham electroacupuncture waist circumference thickness of subcutaneous fat
an observational study of patients with moderate parkinson's disease

Conditions: Parkinson Disease

Summary: the main purpose of this study is to follow and observe a group of people living with parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. while taking part in this study participants will take their usual medication as prescribed. however, the study doctor may recommend adjustments to their medication to provide a better treatment of their parkinson's disease. participation will last from 3 up to 24 months. during visits to the clinic, the study doctor or study nurse will evaluate signs and symptoms of parkinson's disease using several different assessments. at a minimum of 2 visits participants will be asked to undergo 'off'-assessments.


Eligibility criteria:
inclusion criteria: * male or female, aged 50-68 years (both inclusive) at the time of signing informed consent. * diagnosed with parkinson's disease using the movement disorder society (mds) criteria (fulfilling the definition of clinically probable parkinson's disease). * moderate parkinson's disease, e.g. as defined by i) modified hoehn and yahr stage 2-3 in off state and ii) mds-unified parkinson's disease rating scale (mds-updrs) part iii total score greater than or equal to (≥) 30 in off state, both as judged by the investigator. * patient has symptoms that are not adequately controlled by existing oral anti-parkinson's disease medications, i.e., having both on and off periods, as judged by the investigator. * parkinson's disease duration greater than (\>) 5 years and lesser than or equal to (≤) 12 years from diagnosis at the time of signing informed consent. * potential candidate for a future cell therapy transplantation, as judged by the investigator. * life expectancy \>7 years as judged by the investigator. exclusion criteria: * any atypical or secondary parkinson's disease, or non-parkinson's disease-suspected cause(s) of, or contributors to, parkinsonism, as judged by the investigator. * significant drug-induced dyskinesias as judged by the investigator, e.g., as defined by a score of \> 2 in the abnormal involuntary movement scale (aims), in any body part in the on state. * tremor-dominant parkinson's disease, as judged by the investigator. * cognitive impairment predictive of dementia (including parkinson's disease dementia) or other cognitive dysfunction as judged by the investigator, e.g., as defined by montreal cognitive assessment (moca) score ≤ 24, or evidence of major neurocognitive disorder according to the diagnostic and statistical manual of mental disorders v (dsm-v) criteria. * major medical or psychiatric disorder (e.g., depression (montgomery-asberg depression rating scale (madrs) \>20) or psychosis), or other disease making the patient unsuited for participation in the study, as judged by the investigator. * treatment for dystonia or spasticity within 3 months of screening (botox for a focal dystonia is allowed). * substantial neurological symptoms not accounted for by parkinson's disease, including active seizure disorder, as judged by the investigator.
international prospective registry on pre-pectoral breast reconstruction

Conditions: Breast Cancer

Summary: this is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. the aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.

1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. therefore, no risks are anticipated for the patients who will participate in this study. potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.

Eligibility criteria:
inclusion criteria: * female patients older than 18 years old * signed informed consent form * patients undergoing mono or bilateral therapeutic mastectomy * patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh exclusion criteria: * male patients * patients not suitable for surgical treatment * patients undergoing subpectoral reconstruction * patients undergoing breast reconstruction with autologous tissue.

Keywords: breast cancer breast reconstruction pre-pectoral breast prosthesis mastectomy
a registry study of the aeriseal® system or lung volume reduction in patients with advanced emphysema

Conditions: Chronic Pulmonary Obstructive Disease; Emphysema

Summary: the purpose of this study is to provide post market clinical follow-up (pmcf) to obtain long term safety and efficacy information about the aeriseal system treatment in patients with advanced emphysema.

the purpose of this study is to provide post market clinical follow-up (pmcf) to obtain long term safety and efficacy information about the aeriseal system treatment in patients with advanced homogeneous or heterogeneous emphysema.

Eligibility criteria:
inclusion criteria: * confirmation of completion of aeris' post market follow-up continuation study, 03-c10-001plv.

Keywords: aeriseal treatment device breathing copd emphysema polymeric lung volume reduction (plvr) biologic lung volume reduction (blvr) heterogeneous homogeneous respiratory tract diseases lung diseases pulmonary disease, chronic obstructive
quality control of ce-certified phonak hearing aids - 2018_28

Conditions: Hearing Loss; Sensorineural Hearing Loss

Summary: phonak hearing systems pass through different development and study stages. at an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. if the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. afterwards, and prior to product launch, the phonak hearing systems undergo a final quality control in terms of clinical trials. this is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. this will be a clinical investigation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

in this study a comparison with two ce-labeled phonak receiver-in-the-canal (ric) devices is done. the experimental device and the active comparator will be compared regarding sound quality perception and speech intelligibility in quiet and in noise. the experimental device contains direct connectivity functionality which will be investigated in terms of streamed audio quality, streaming stability and usability preferences of functions and features which are related to direct connectivity. the active comparator device does not contain direct streaming functionality. this will be a clinical investigation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years, mild to moderate hearing loss) without hearing aid experience * good written and spoken (swiss) german language skills * healthy outer ear * ability to fill in a questionnaire (p/ecrf) conscientiously * willingness to wear receiver in the canal hearing aids * informed consent as documented by signature * owning a compatible smartphone exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments in stäfa (switzerland) * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * known psychological problems * central hearing disorders
personalized nutrition for type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this project will compare medical nutrition therapy personalized by continuous glucose monitor (cgm) feedback to control interventions in participants with type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * at least 18 years of age * previous diagnosis of t2dm * hba1c of 6.8-8.5% exclusion criteria: * type 1 diabetes mellitus * treatment with insulin, sulfonylurea, or meglitinide * use of nondiabetic medications that affect blood glucose control (such as corticosteroids) * bmi \<25 kg/m2 or \<23 kg/m2 for participants who self-identify as asian * weight change \>5 pounds in the 3 months prior to study enrollment * estimated glomerular filtration rate \<60 ml/minute/1.73 m2 * pregnancy or immediate plans to become pregnant 8) breastfeeding 9) anemia (which would affect measurement of hba1c) 10) changes to glucose lowering medications, including change in dose, in the 3 months prior to enrollment 11) presence of any disease that would make adherence to the protocol difficult."

Keywords: type 2 diabetes nutrition cgm
low level lazer therapy effect on vertebral artery blood flow in elderly with cervical disc degeneration

Conditions: Disc Degeneration

Summary: this study will include 60 elderly patients with cervical disc degeneration, from both gender who are aged from 60 - 75 years old.

the 60 patients will divided into two groups, with 30 patients in each group. group(a): will receive low level lazer and exercises for three times per week for 12 weeks. group (b): will receive only exercises. resistivity index of both right and left vertebral arteries will be measured before and after the 12 weeks.

Eligibility criteria:
inclusion criteria: 1. elderly patients with age range between 60 and 75 years old. 2. with cervical disc degeneration. exclusion criteria: 1. patients with uncontrolled hypertension. 2. patients with uncontrolled diabetes mellitus. 3. patients with severe cardiac or chest diseases.
effect of nutrition training on mothers' nutrition pattern, breast milk and newborn intestinal microbiota

Conditions: Microbial Colonization; Nutrient Deficiency

Summary: objective: the aim of this study was to investigate the effects of nutrition training on mothers' nutrition pattern, breast milk and newborn intestinal microbiota. materials and methods: the study was conducted as a non-randomized controlled experimental study. the population of the study consisted of mothers and their babies who delivered vaginally, breastfeeded their babies at the end of the second postnatal day and delivered at the maternity ward of the malatya training and research hospital beydağı campus. the sample of the study consisted of 120 mothers, 57 of whom were experimental and 63 of them were in the control group. in this study, a sub-sample of 15 mothers and their infants was selected and microbiota of breast milk and stool samples were examined. in the first interview with the mothers in the experimental and control groups, participant identification form, btskf were applied as a pre-test and stool samples of breast milk and newborn were taken. then, the mothers in the experimental group were given nutritional education. in addition, motivational messages were sent to mothers' phones once a week. mts in the experimental and control groups were filled with btskf as an intermediate test at the first month and post-test at the third month and stool samples of breast milk and newborn were collected at the mothers' own homes. during these visits, nutrition counseling was given to the mothers in the experimental group.

nutrition is very important from intrauterine life to old age for a healthy and productive life. however, the importance of pregnancy, childbirth and breastfeeding during the special stages in which the woman is experienced in her life process increases slightly (ho et al., 2016; erick, 2018; tekiner and ungan, 2014). healthy nutrition is a key concern for the health of the baby during pregnancy, childbirth and breastfeeding periods as well as the health of the mother (taşkın, 2016; samur, 2008). intrauterine life is transmitted by placental way and in the postpartum period, breast milk is fed to the baby. therefore, in order to ensure optimal growth and development of the baby, the mother needs adequate, regular and quality nutrition (ho et al., 2016; erick, 2018; tekiner and ungan, 2014).

Eligibility criteria:
inclusion criteria: * being literate, * being within 48 hours after delivery, * no disease / complications in mother and newborn, * delivery at term (according to the first day of the last menstrual period). exclusion criteria: • a mother's inability to breastfeed her baby for a variety of reasons, either short or long term (mastitis, abscess).

Keywords: microbiata food groups
effect of evogliptin on bone metabolism in human

Conditions: Diabetes Mellitus, Type 2; Osteoporosis

Summary: this study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.


Eligibility criteria:
inclusion criteria: * postmenopausal healthy women (at least 5 years) * bmi 18\~30 kg/m2 exclusion criteria: * presence or history of hypersensitivity or allergic reactions to any drug * clinically relevant abnormal medical history or present disease * presence or history of drug abuse * participation in other clinical trial within 2 months before dose. * bood donation during 2 months or apheresis during 1 month before the study. * use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose. * use of any drug which can affect bone metabolism such as sex hormones or their receptor related medicine, calcitonin or parathyroid hormone related medicine, systemic corticosteroid, bisphosphate, or etc. * smoking of more than 10 cigarettes/days within 3 months before first dose. * use of alcohol over 21 units/weeks * subject judged not eligible for study participation by investigator.
chemotherapy alone versus chemotherapy plus targeted therapy as adjuvant therapy for initially unresectable colorectal cancer liver metastases

Conditions: Colorectal Cancer Metastatic

Summary: chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce the rate of both intrahepatic and extrahepatic recurrence in initially unresectable crlm patients. those with kras/nras/braf mutated tumors or cycle of conversion therapy ≤ 4 can benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with a tolerable toxicity profile.

this multi-center study enrolled consecutive patients with initially unresectable crlm who underwent conversion therapy or radiofrequency ablation (rfa) and achieved no ned status between june 1, 2013, and june 30, 2020, from zhongshan hospital of shanghai, zhongshan hospital of xiamen, cancer hospital of beijing. the inclusion criteria were as follows: (1) with histologically confirmed crc; (2) with initially unresectable synchronous liver metastases (lms); (3) accepted conversion therapy and successfully converted into resectable status; (4) underwent r0 intestinal and hepatic resection; (5) accepted adjuvant therapy. the exclusion criteria were as follows: (1) r1/r2 resection; (2) extrahepatic metastases; (3) accepted postoperative monotherapy; (4) lack of follow-up data. according to the adjuvant therapy regimen (with or without targeted therapy), the cohorts were divided into ca cohort and ct cohort. the study was approved by the ethics committee of three medical centers and was adhered to good clinical practice guidelines and the declaration of helsinki. written informed consent was obtained from all participants.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 75 years; 2. histologically confirmed crc; 3. initially unresectable synchronous liver metastases (lms); 4. accepted conversion therapy and successfully converted into resectable status; 5. underwent r0 intestinal and hepatic resection; 6. accepted adjuvant therapy. exclusion criteria: 1. r1/r2 resection; 2. extrahepatic metastases; 3. accepted postoperative monotherapy; 4. lack of follow-up data.
weight loss through mayo clinic diet

Conditions: Obesity

Summary: the purpose of study is to evaluate the efficacy of the mayo clinic diet in clinically significant weight loss (\>5%) versus usual care. we also wish to evaluate the feasibility, barriers to completion, and sustainability of this intervention at the 24, and 52-week marks. lastly, we aim to study the change in participants body composition and quality of life at the end of this intervention.


Eligibility criteria:
inclusion criteria: * males and females (non-pregnant) 18-64 * bmi \> or = to 25 kg/m2 * ability to read and understand english. (as the mayo clinic diet book and app are only available in english) exclusion criteria: * have a current diagnosis of melanoma or cancer diagnosis * currently breastfeeding * pregnant, or planned to be pregnant within 6 months * have a diagnosis of type 1 or 2 diabetes mellitus * had weight loss surgery within the last year * currently participating in another lifestyle weight loss program or taking medications for weight loss * have lost 5% or more of their weight in the last six months * have a history of eating disorders * have planned surgery in the next 6 months.